In the manufacture of solid dosage forms (tablets, caplets, or pills) of pharmaceutical solids and semi-solid dosage forms (gel-tabs) of pharmaceutical (non-packed powders) solids, one of the critical processing steps is the blending and mixing of the active pharmacological ingredient(s) with that of the inactive non-pharmacological ingredient(s) in a blender or mixer tank. Before further processing steps are undergone for this pharmaceutical product, blended powder samples are taken in order to be analyzed by the quality control department in order to determine if the active ingredients have been blended properly and are uniformly distributed within the blended powder. Such a test is called a blend uniformity analysis test or a homogeneity test. This procedure is referred to as "Process Validation" which requires pharmaceutical manufacturers to show proper control of the manufacturing process of any pharmaceutical drug. One of the requirements is to show evidence of proper blending of pharmaceutical actives and excipients. After the actives and excipients (non-active ingredients) are blended together in a blender, samples are taken from different sections of the blend and analyzed for proper distribution of the active ingredients.
In order to achieve proper information, the sample size should range from 1 to 3 times the mass of one unit dose. The sampled material should be representative of the blended pharmaceutical. Since the mass of one unit dose varies considerably from formula to formula, a single unit dose sampler with a nonadjustable sample volume would require multiple samplers.
In addition, since the size of blenders vary considerably with the added problem of limited clearance, the necessity of multiple samples, along with the requirement of assuring that the sampler can be thoroughly cleaned between sampled pharmaceuticals, would require pharmaceutical manufacturers to invest heavily in multiple samplers.
There remains a need for a rotatable batch sampling device having a wedge-shaped cone tip and a center section cut-out area for inserting into a dry powder blend that verifies the proper distribution of the active pharmacological ingredients, and enables the withdrawing of multiple precise samples of varying volumes without appreciably disturbing the powder blend matrix or the composition of the matrix when sampling, in order to insure accurate quality control testing. This must be done without appreciably disturbing the powder blend matrix when sampling. Thus verifying the proper distribution of the active pharmacological ingredients. Additionally, the sampling device must have the capability of taking a plurality of precise samples simultaneously of the dry blended powder at various depths by utilizing sampling cups having varying sample volumes.